Sr. Manager, Medical Review

Job Title: Sr. Manager, Medical Review
Location: Remote
Contract: 1 year with possible extension

What are the top 5 skills/requirements this person is required have?
1. Represent Medical in the Material Review Process (to guarantee medical, clinical, and scientific data accuracy, relevance, and objectivity).
2. Provide proactive guidance as needed for brand concepts and campaigns. Collaborate with commercial business partners early in the development of promotional materials to enhance efficiency.
1. Serve as medical / scientific expert to advise commercial colleagues on proper product and disease state claims development.
2. Engage with Medical Affairs Directors to ensure promotional materials are aligned with medical strategy and tactics.
3. Maintain a comprehensive knowledge of disease pathophysiology, diagnostic techniques, appropriate therapeutic approaches, competitive landscape, and patient outcomes.

What years of experience, education, and/or certification is required?
Minimum of 1 year of experience in a medical review role

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Knowledge/expertise of Gastroenterology and/or Immunology therapeutic area

What is the environment that this person will be working in (i.e. group setting vs individual role)? Remotely, both individually (reviewing) and in a group setting (providing feedback and attending review meetings to review upcoming and current promotional content).

Other notable details about the environment from the hiring manager about this role:
Role works cross-functionally with multiple internal stakeholders/partners (i.e. regulatory review, legal, ethics, Medical affairs, commercial).

What positions/background experience do you feel are successful in this role:
Previous experience within Medical Affairs or medical information

JOB SUMMARY:
• Electronically review promotional and other materials and provide medical expertise and review as described above. Includes discussing and collaborating with appropriate review colleagues from other functions.
• Attend, advise, and approve in review meetings as the lead Medical Reviewer for the designated therapeutic area.
• Responsible for providing proactive guidance as needed for brand concepts and campaigns.
• Support review of non-promotional materials, and development and review of other related medical affairs materials as required.
• Support medical affairs tactics as required

KEY DUTIES AND RESPONSIBILITIES:
• For designated therapeutic area of responsibility, attends, advises, and approves in review meetings as the lead Medical Reviewer for promotional review.
• Functions as lead Medical Reviewer and sign-off for all promotional materials.
• Leads and contributes to medical promotional review
• Provides proactive guidance as needed for brand concepts and campaigns. Engages Commercial business partners early in the development of promotional materials to enhance efficiency.
• Supports non-promotional review, and other medical affairs initiatives and tactics as required and if appropriate.
• Review of commercial promotional and non-promotional content as well as medical content

MINIMUM REQUIREMENTS
Education and Experience
• Advanced health science education or equivalent combination of education and experience required. (PhD, PharmD, or MD preferred)
• 1-5 years experience in clinical practice, academic research, pharmaceuticals, regulatory/scientific, or medical science liaison (MSL) environment
• Previous experience as Regulatory or Medical reviewer for promotional and non-promotional materials preferred (ideally greater than 1 year).
• Immunology/Gastroenterology experience preferred
• Medical affairs or medical communications experience preferred

Essential Skills and Abilities
• Ability to learn and convey medical information effectively.
• Works individually (reviewing materials electronically)
• Works collaboratively with other review team members
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